... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
Senior Director / Executive Director, US Regulatory Strategy
Boston, MA · On-site
$150 - $180/hr
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
Senior Director / Executive Director, US Regulatory Strategy
Boston, MA · On-site
$150 - $180/hr
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
Quick apply
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
Yearly Registration of US FDA Establishment License and updates to product listings; Export documentation to support shipping. Essential Job Functions: * Under supervision, coordinate, compile, and ...
Yearly Registration of US FDA Establishment License and updates to product listings; Export documentation to support shipping. Essential Job Functions: * Under supervision, coordinate, compile, and ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
Quick apply
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School o
Claremont, CA · On-site
$2.5K - $15K/mo
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School of Applied Life Sciences Position Overview The primary responsibilities of the Adjunct Faculty ...
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School o
Claremont, CA · On-site
$2.5K - $15K/mo
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School of Applied Life Sciences Position Overview The primary responsibilities of the Adjunct Faculty ...
Sr Manager, Regulatory Affairs
Englewood, CO · On-site
$120K - $150K/yr
US FDA Premarket Approval * US FDA HUD/HDE for Humanitarian Use/Humanitarian Device Exemption * US FDA Section 520(b) Custom Device Exemption * US FDA Compassionate Use * US FDA Investigational ...
Sr Manager, Regulatory Affairs
Englewood, CO · On-site
$120K - $150K/yr
US FDA Premarket Approval * US FDA HUD/HDE for Humanitarian Use/Humanitarian Device Exemption * US FDA Section 520(b) Custom Device Exemption * US FDA Compassionate Use * US FDA Investigational ...
Surgical Oncologist - FDA
Bethesda, MD · On-site
... us. FDA CDRH - Medical Officer (Surgical Oncologist) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health.
Surgical Oncologist - FDA
Bethesda, MD · On-site
... us. FDA CDRH - Medical Officer (Surgical Oncologist) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health.
Surgical Oncologist - FDA
Bethesda, MD · On-site
... us. FDA CDRH - Medical Officer (Surgical Oncologist) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health.
Surgical Oncologist - FDA
Bethesda, MD · On-site
... us. FDA CDRH - Medical Officer (Surgical Oncologist) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health.
... us. FDA CDRH - Medical Officer (Surgical Oncologist) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health.
... us. FDA CDRH - Medical Officer (Surgical Oncologist) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health.
Authors US FDA premarket submissions (e.g., 510(k), Q-submissions) and international submissions with collaboration from key staff in Product Development, Operations, Marketing, and Quality for ...
Authors US FDA premarket submissions (e.g., 510(k), Q-submissions) and international submissions with collaboration from key staff in Product Development, Operations, Marketing, and Quality for ...
Senior Regulatory Affairs Specialist
Palo Alto, CA · On-site +1
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system-the first FDA-cleared, portable, ultra-low-field ...
Senior Regulatory Affairs Specialist
Palo Alto, CA · On-site +1
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system-the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system--the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system--the first FDA-cleared, portable, ultra-low-field ...
Director Commercial Quality US
Parsippany Troy Hills, NJ · On-site
$173 - $216/hr
Health Authority and US FDA interactions; continuous improvement initiatives; and quality/regulatory compliance of commercial engagements (internal and external). This role also informs strategic ...
Director Commercial Quality US
Parsippany Troy Hills, NJ · On-site
$173 - $216/hr
Health Authority and US FDA interactions; continuous improvement initiatives; and quality/regulatory compliance of commercial engagements (internal and external). This role also informs strategic ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system--the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system--the first FDA-cleared, portable, ultra-low-field ...
Initiates continuous improvement of processes and standards based on FDA Regulations and ... Manages the Commercial Quality Teams in US that provide Quality and Compliance oversight of ...
Initiates continuous improvement of processes and standards based on FDA Regulations and ... Manages the Commercial Quality Teams in US that provide Quality and Compliance oversight of ...
Sr. Regulatory Affairs Specialist II
Ponte Vedra, FL · On-site +1
Authors US FDA premarket submissions (e.g., 510(k), Q-submissions) and international submissions with collaboration from key staff in Product Development, Operations, Marketing, and Quality for ...
Sr. Regulatory Affairs Specialist II
Ponte Vedra, FL · On-site +1
Authors US FDA premarket submissions (e.g., 510(k), Q-submissions) and international submissions with collaboration from key staff in Product Development, Operations, Marketing, and Quality for ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop system-the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop system-the first FDA-cleared, portable, ultra-low-field ...
Us Fda information
What is the US FDA?
The US FDA, or United States Food and Drug Administration, is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. The FDA regulates and oversees the approval of new drugs and medical devices, monitors food safety, and enforces regulations to ensure products meet safety standards. The agency also provides guidance to industry and the public on issues related to health and safety.
What are the key skills and qualifications needed to thrive as a US FDA Regulatory Affairs Specialist?
To thrive as a US FDA Regulatory Affairs Specialist, you need in-depth knowledge of FDA regulations, strong analytical skills, and a degree in life sciences or a related field. Familiarity with regulatory submission platforms like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are highly valuable. Exceptional attention to detail, problem-solving abilities, and strong written and verbal communication skills help professionals excel in this role. These skills ensure compliance with complex regulations, effective communication with regulatory agencies, and successful product approvals.
What are some common challenges faced by professionals working in roles related to the US FDA?
Professionals working in roles related to the US FDA often encounter challenges such as staying updated with frequently changing regulations and ensuring strict compliance with all applicable guidelines. They may also face tight deadlines when preparing documentation for product submissions or responding to regulatory inquiries. Collaboration across multidisciplinary teams—including legal, scientific, and quality assurance departments—is essential, which can require strong communication and project management skills. Navigating complex processes and balancing regulatory requirements with business needs are key aspects of the role.
What is the difference between Us Fda vs Us Pharmacist?
| Aspect | Us Fda | Us Pharmacist |
|---|---|---|
| Required Credentials | Regulatory knowledge, possibly a degree in health sciences | Doctor of Pharmacy (PharmD), state licensure |
| Work Environment | Regulatory agencies, laboratories, compliance offices | Pharmacies, hospitals, clinics |
| Industry Usage | Regulatory oversight, policy development | Patient care, medication dispensing |
| Common Search/Comparison | Regulatory roles, compliance jobs | Clinical roles, medication management |
The main difference is that Us Fda professionals focus on regulation, compliance, and policy within the healthcare industry, often working for government agencies. In contrast, Us Pharmacists are healthcare providers directly involved in patient care and medication dispensing. While both roles require healthcare knowledge, their work environments and responsibilities differ significantly.
What qualifications do I need for US FDA jobs?
US FDA jobs typically require a bachelor's degree in a relevant field such as science, engineering, or healthcare, along with relevant work experience. Some positions may require advanced degrees or professional certifications, and strong analytical, communication, and regulatory knowledge are often essential. Specific qualifications vary depending on the role and level of responsibility.
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What states have the most Us Fda jobs?
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What job categories do people searching Us Fda jobs look for?
The top searched job categories for Us Fda jobs are:
Senior Director / Executive Director, US Regulatory Strategy
San Francisco, CA • On-site
Full-time
Re-posted 18 hours ago
Job description
We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology and pharmaceutical clients developing innovative and complex therapies.
The successful candidate will serve as a trusted strategic advisor to clients pursuing late-stage development and commercialization of complex biologics, such as combination products, with a particular emphasis on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable.
In addition to technical regulatory leadership, this role requires strong client-facing skills, business acumen, and the ability to contribute to the growth of a boutique consultancy through thought leadership, client development, and industry engagement.
Key Responsibilities
Regulatory Strategy Leadership
Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management.
Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics.
Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy.
Lead all aspects of health authority interactions
Support regulatory due diligence activities.
Experience with EMA and other international health authorities is highly valued.
Client Leadership and Consulting
Serve as a senior strategic advisor and primary client contact.
Build long-term biotech and pharmaceutical client relationships.
Lead multidisciplinary consulting teams and mentor junior staff.
Deliver high-quality regulatory recommendations, reports, and presentations.
Business Development and Growth
Support business development, proposals, and client pitches.
Represent the organization at conferences and industry events.
Develop thought leadership materials and support company growth.
Requirements
Required Qualifications
Degree in a life sciences discipline
Significant industry experience
Deep expertise in US FDA regulatory strategy for biologics.
Multiple successful BLA experiences with direct FDA interactions.
Significant experience with complex modalities, such as combination products and cell and gene therapies
Strong consulting, leadership, communication, and presentation skills.